BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2191846 · Received July 22, 2011

    Report

    Report Number
    3004209178-2011-05669
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN INS LOW BATTERY WAS REPORTED WHEN THE DEVICE WAS NEAR EOS/EOL. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. IMPEDANCE MEASUREMENTS WERE "NORMAL" POST IMPLANT. ACTUAL IMPEDANCE VALUES WERE NOT OBTAINED. REPROGRAMMING WAS (B)(6) 2011. ON (B)(6) 2011, PT WAS PROGRAMMED TO A UNIPOLAR CONFIGURATION AT 2V AND INTERROGATION PARAMETERS WERE 7.5V; 0+/3-, >4000 READING ON COMBINATIONS USING 3 (PROGRAM 4). LOW BATTERY READING WAS DISPLAYED. A F/U VISIT WAS SCHEDULED (B)(6) 2011. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT V598059.| PROGRAMMER: MODEL 3037, LOT NJD119165N.| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT NJD119165N| LEAD: MODEL 3889, LOT V598059